Generics UK Ltd v Synaptech Inc

A reference was made to the Court of Justice concerning the meaning of first authorisation in Article 13(1) of Council Regulation (EEC) No 1768/92. The Court of Appeal did not decide whether that expression means the first authorisation complying with Directive 65/65/EEC, or any authorisation enabling the product to be marketed in the Community or EEA. It also referred whether an earlier Austrian authorisation, granted under non-compliant national legislation and later withdrawn, could qualify. The appeal was stayed pending the preliminary ruling.

Generics challenged the expiry date of Synaptech’s supplementary protection certificate for galantamine. It sought rectification of the patent register under section 34 of the Patents Act 1977. The Patents Court rejected the claim in a judgment dated 20 May 2009, and Generics appealed from the subsequent order dated 9 June 2009.

The dispute concerned Article 13(1) of Council Regulation (EEC) No 1768/92. The parties disagreed whether the relevant first authorisation was the Swedish authorisation issued in March 2000, which complied with Directive 65/65/EEC, or an earlier Austrian or German authorisation granted under national legislation. The Court of Appeal referred two questions to the Court of Justice under Article 234 EC and requested joinder with Case C-195/09, Synthon v Merz.

The Court of Appeal made a preliminary reference without hearing oral argument from the parties and stayed the appeal pending the ruling of the Court of Justice.

1. Article 13(1). The Court referred whether the first authorisation to place a product on the market in the Community must be the first authorisation issued in accordance with Directive 65/65/EEC, now replaced by Directive 2001/83/EC, or whether any authorisation enabling the product to be placed on the market in the Community or EEA is sufficient.
2. Earlier Austrian authorisation. If Directive compliance was required, the Court referred whether the 1963 Austrian authorisation for galantamine, granted under national legislation that did not comply with Directive 65/65/EEC, never amended to comply with that directive and withdrawn in 2001, could nevertheless be treated as a compliant authorisation.
3. Deeming provisions. The reference identified Articles 3(b), 13(1) and 19(1) of Council Regulation (EEC) No 1768/92, including the EEA and EU deeming provisions. The parties advanced competing submissions on whether those provisions affected the relevance of the Austrian authorisation and the calculation of the certificate’s expiry date.
4. Orders. The questions were referred under Article 234 EC. The Court requested joinder with the pending reference in Case C-195/09, Synthon v Merz, stayed all further proceedings, directed transmission of the order and schedule under CPR Pt 68, reserved costs and granted liberty to apply.

• Court of Appeal (Civil Division): In [2009] EWCA Civ 1119, the Court referred two questions concerning Council Regulation (EEC) No 1768/92 to the Court of Justice, requested joinder with Case C-195/09, and stayed the appeal.
• Patents Court: The claim for rectification of the patent register was rejected in a judgment dated 20 May 2009. The judgment citation was not stated in the judgment.